Ionized Calcium Electrode

Measuring concentration of ionized Calcium in whole blood, serum, and plasma samples.

Registry build 21.09.26
1manufacturer
1catalogue number

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code JFP
Manufacturer City Province Registered as Device types
Edan Instruments, Inc. Shenzhen Guangdong Contract manufacturer 56

Record

Regulatory record for Ionized Calcium Electrode
Listed by Diamond Diagnostics Inc., Hungary
FDA product code JFP
Device type Electrode, Ion Specific, Calcium
Device class Class 2
Regulation 21 CFR 862.1145
Establishment Contract manufacturer, Manufacturer, Exporter
Premarket notification Exempt
Record published 2023-06-05

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, serial number

Catalogue Numbers

Catalogue numbers for Ionized Calcium Electrode
Catalogue number Size Status
AV-BP0360D In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Stat Profile Nova Biomedical Corporation 9
Nova Nova Biomedical Corporation 8
Calcium Electrode Medica Corp. 2
SC90 Radiometer Medical APS 2
pH/pCO2/pO2/Na/K/Ca Analyzer Medica Corp. 2
Na/K/Cl/Ca/Li Solution pack Medica Corp. 1
Rinse Solution S4980 REF 944-130 Radiometer Medical APS 1
Nova/Stat Profile Nova Biomedical Corporation 1
Rapidpoint® 350 Sampler Module Siemens Healthcare Diagnostics Inc 1
RAPIDLab® 1200 pH Electrode Fill Siemens Healthcare Diagnostics Inc 1
Roche 9180 Electrolyte Analyzer Roche Diagnostics Gmbh 1
E-Ca Cassette Carton Opti Medical Systems Inc. 1

Showing 12 of 33. All products under Electrode, Ion Specific, Calcium

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer